Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial

BEVERLY, MA—February 26, 2014 – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the first patients have been enrolled and treated in the Company’s Phase 2b clinical trial of Brilacidin in patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

The trial compares three different dosing regimens of Brilacidin (two single-dose regimens and one 3-day regimen) to a standard 7-day regimen of daptomycin, a drug marketed in the United States by Cubist Pharmaceuticals under the brand name Cubicin.  This is an important milestone for the Company as there are currently no Food and Drug Administration-approved drugs that have a dosing regimen of less than seven days in duration.  The data from this trial, if positive, will be used for dose selection in an upcoming Phase 3 program.

Brilacidin is the lead compound in a novel class of immunomodulatory antimicrobials known as defensin-mimetics.  Similar to the body’s innate immune system, these compounds are also active on the surface of skin and mucous membranes. This unique class of antimicrobial chemistry presents numerous other drug development opportunities for Cellceutix, such as treatment of bacterial infections of the eye and ear, as well as the prevention and treatment of oral mucositis in cancer patients.

“We are very pleased that clinical trials of Brilacidin for ABSSSI are underway,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix.  “Patients are now being treated with Brilacidin at one clinical site and we anticipate that all four U.S. sites in the trial will be up and running within one week.  As the trial progresses, we expect that approximately 40 patients will be enrolled each month in the 200-patient study.”

Interested parties are encouraged to follow the progression of the clinical trial on the Food and Drug Administration website at http://www.clinicaltrials.gov/ct2/show/NCT02052388?term=ctix&rank=2, which is expected to be updated to its current status in a matter of days.